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    Senior V&V Engineer

    Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome engineer to join our core Validation team that is reshaping MIS.

    The validation engineer will be an integral part of all product research, development, integration and testing. This position requires agility, attention to details, and a diversified skillset to head many different tasks and operations. If you are up for the challenge, don’t miss this opportunity, we’d love to have you on our team.

    Responsibilities

    • The senior V&V engineering role involves quality & test advocacy, promoting design for testability and resolution of issues that block the testing effort
    • SME in the R&D for testing methodologies and planning – guidance and review of V&V materials (plans, protocols, reports) produced by other team members
    • Develop and implement research methodologies and statistical analysis plans to test and evaluate developmental prototypes as well as final products used in all phases of products development and processes
    • Write test plans, protocols, reports and conduct formal testing to verify and validate the safety and efficacy of new and existing Human Xtensions’ products
    • Work with cross functional teams (product managers, regulatory, system engineers, mechanical and SW) to evaluate and maintain user interface requirements, usability risk mitigations and plans, usability formative and summative studies
    • Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)
    • Supporting regulatory documentation and submissions

    Requirements

    Basic Qualifications

    • Bachelor’s / Master’s degree in Engineering from a well-known university
    • 5 years of V&V experience within the medical devices industry (complying to ISO 13485, FDA CFR 820)
    • Strong communication skills & excellent teamwork and collaboration
    • Strong technical orientation for understanding multi-disciplined systems
    • Excellent technical writing skills (English)
    • Experience with statistical methods and tools
    • Responsible, hands-on approach – performing mechanical & electrical tests
    • Attention to details
    • Experience in sterile / disposable devices
    • The position is full time

    Preferred Qualifications

    • Experience with Design of Experiments methodologies
    • Experience in design of multidisciplinary products
    • Electronical/Mechanical background
    • Basic knowledge in Solidworks
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